MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-4-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): two axium prime coils were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser track.The unknown micro catheter used in the event was not returned.Visual inspection/damage location details: (pli-10) the axium prime coil was returned within introducer sheath.The axium prime coil pushwire kinked at ~3.9cm and bent at ~134.4cm from proximal end.The axium implant coil was found to be broken and returned within introducer sheath.The implant coil was unable to be pushed out from introducer sheath for further analysis as it was found to be stuck.The implant coil was found to be stretched and damaged.No other anomalies were observed.(pli-20) the axium prime coil was returned with introducer sheath.No bends or kinks were found with the axium implant coil pushwire.The axium implant coil was found to be stretched and damaged within introducer sheath.The implant coil was unable to be pushed out from introducer sheath for further analysis as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coils could not be used for resistance testing with an in-house micro catheter due to their damaged condition.Conclusion: based on the device analysis and the reported information, the customers report of ¿coil resistance/stuck in catheter¿ was unable to be confirmed.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the concerto coil prior to use, and lack of continuous flush during delivery.The model or lot number for the unknown micro catheter used during the event were not provided; therefore, compatibility could not be assessed.The root cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the patient had an aneurysm in the left ophthalmic artery segment.A microwire with a microcatheter was advanced into the aneurysm sac.An apb-2.5-4-3d coil was first selected to form a basket.When the second apb-2-4-3d spring coil was placed, it was found that the spring coil could not be pushed out.For the safety of the procedure, a new coil of the same specification was used instead.Subsequently, an apb-1.5-4-3d coil was placed, but it also failed to pushed out.The apb-1.5-4 coil was withdrawn, and a 1.5-3 coil was successfully detached and implanted.Additional coils, including an apb-1-2-3d and an apb-1-1-hx, were sequentially placed, achieving a dense embolization upon angiography.The procedurewas then completed.The coil was stuck in the distal section of the catheter.There was no damage to the catheter.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured left ophthalmic artery aneurysm.It was noted the patient's vessel tortuosity was normal.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23359618
• Report Number: 9617601-2025-02161
• Device Sequence Number: 13003050
• Product Code: KRD
• UDI-Device Identifier: 00847536021198
• UDI-Public: (01)00847536021198(17)270306(10)228436824
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APB-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 228436824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 69 KG